ConvaTec In Hot Water With The FDA After Patients Death, Injuries

The FDA says that ConvaTec failed to seek 510(k) review for its recalled Flexi-Seal Control fecal management kit, which was associated with 12 injuries and 1 patient death. ConvaTec in FDA hotseat after patients injured

Device maker ConvaTec landed in the FDA's cross hairs after the company recalled a device that the agency says never underwent regulatory review.

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